Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
mometasone furoate · 22 trials · 10 indications
At Baseline, the Investigator and participant jointly evaluated the signs and symptoms of congestion/obstruction. After Baseline, participants scored the signs and symptoms of congestion/obstruction every morning immediately prior to dosing using a morning instantaneous congestion/obstruction score. This score reflected the participant's condition at that time (instantaneous) and ranged from 0 to 3 (0=none, 1=mild, 2=moderate, 3= severe), with a lower score indicating less congestion/obstruction. Congestion/obstruction scores were averaged over Weeks 1-4 of the treatment period. Data are compared using Least Square (LS) Means. LS Mean Change from Baseline = LS Mean Score averaged over Weeks 1-4 - LS Mean Score for Baseline.
An endoscopic nasal examination was performed by the Investigator. Bilateral nasal polyps were scored as follows for each notril (left and right): 0=no polyps, 1=polyps in middle meatus not reaching below inferior border of middle turbinate, 2=polyps reaching below inferior border of middle turbinate but not inferior border of inferior turbinate, 3=large polyps reaching to or below the lower borders of the inferior turbinate or polyps medial to the middle turbinate. Total polyp size score ranged from 0 to 6 (scored 0 to 3 for each nostril), with a lower score indicating smaller-sized polyps. LS Mean Change from Baseline = LS Mean Score for Week 16 - LS Mean Score for Baseline.
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\]). Baseline is the average score from the 3 days prior to the first dose of study drug.
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe symptoms. PRIOR (the subject's status over the previous 12 hours \[reflective\])
Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours \[reflective\])
To explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). The Rhinasthma is a questionnaire that consists of 30 items and for each of them subjects had to indicate on a Likert scale (1=not at all; 5=very much) the degree of limitation or discomfort caused by each problem. Possible total best score = 150 and possible total worst score = 30.
Changes in adenoid size were assessed by nasopharyngoscopic examination and were determined using the Adenoid/Choana (A/C) Index. Grades were assigned to intervals of A/C ratio percentages: grade I (0-25%), II (26-50%), III (51-75%) and IV (76-100%). Changes in adenoid size were expressed as the mean difference between grades at baseline and study visit. Positive values indicated a decrease in adenoid size, a 0 value indicated that size remained the same, and negative values indicated an increase in adenoid size.
TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.
TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 9.
TNSS was defined as the sum of the following four nasal symptoms: rhinorrhea, nasal congestion/stuffiness, nasal itching, and sneezing; each symptom scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. The best possible score on this scale is 0 and the worst possible score on this scale is 12.
TOSS was defined as the sum of the following three ocular symptoms: redness of eyes, itching/burning eyes, and tearing/watering eyes; each symptom scored on a scale of 0=none, 1=mild, 2=moderate, and 3=severe. The best possible score on this scale is 0 and the worst possible score on the scale is 9.
The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to \<18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level.
The mean change from baseline at study day 8 was calculated for TNSS as assessed by the investigator. TNSS was a composite of the individual nasal symptom scores of discharge (rhinorrhea), stuffiness, sneezing, and itching. The 4 individual nasal symptom scores were rated by the investigator at the visit as follows: 0=none, 1=mild, 2=moderate, 3=severe. TNSS was the sum of the 4 individual nasal symptom scores (range= 0-12; higher score indicating more frequent/severe nasal symptoms). For each participant, individual scores were totaled and used to calculate the change from Baseline in TNSS at the visit. Participant changes were then used to calculate the mean change for each treatment group at that visit. Change from Baseline = visit score - Baseline score (Day 1 visit). Negative changes indicate a decrease in symptom severity.
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment.
Change from baseline averaged over study Day 1 through study Day 15 was calculated for Total Nasal Symptom Score, based on participant diaries. Participants scored 4 symptoms (rhinorrhea, stuffiness, itching, sneezing) in their diaries using the following scale: 0=none, 1=mild, 2=moderate, 3=severe. The Total Nasal Symptom Score was the sum of the 4 individual scores (range=0-12; higher score indicating more frequent/severe nasal symptoms.) Change from baseline was the 15-day average score minus the baseline score. Scores were recorded twice daily, in the morning (AM) and night (PM). Average AM/PM scores were first calculated separately, then averaged together to obtain the 15-day average score. Baseline score was an average of the 3 AM scores and 3 PM scores preceding treatment. Negative changes indicated a decrease in symptom severity.
Time to onset of relief of nasal stuffiness/congestion, rhinorrhea, nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of eyes, and itching of ears or palate was assessed by the participant using diary response data in the morning and night for the first 3 days of treatment. The participants were asked to rate their relief on the following scale: 1=complete, 2=marked, 3=moderate, 4=slight, and 5=none. If a participant recorded a degree of relief that was at least moderate (3 or below), they answered the question, "When did you first experience noticeable relief?" and noted the date and time. The data were analyzed using a log ranked test and with a Kaplan-Meier estimate. Any participant who did not experience at least moderate relief by the end of 72 hours was considered censored at that time in the analysis. Time to onset of relief is presented in hours.
TNSS evaluated participant nasal symptoms of discharge (rhinorrhea), stuffiness, sneezing, and itching, as rated in their diary in the morning (AM) and evening (PM). The 4 individual symptom scores rated as follows: 0 = none, 1 = mild, 2 = moderate, 3 = severe. TNSS was the sum of the 4 individual symptom scores (range= 0-12, higher score indicating more frequent/severe nasal symptoms). For the 15 day interval, participant individual daily scores were totaled and averaged over interval (AM and PM computed separately then averaged) and used to calculate the overall average change from Baseline. Participant average changes were then used to calculate the mean change for each arm for the interval. Average change from Baseline for Days 1-15 = average post-treatment score (Days 1-15) - Baseline average score (average of the Baseline AM/PM diary scores from 3 consecutive days prior to Baseline visit). Negative changes from baseline indicate a decrease in symptom severity.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants with at least one AE was reported for each treatment group.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an AE. The number of participants who discontinued due to an AE was reported for each treatment group.
| Arm | Type | Description |
|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | EXPERIMENTAL | Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks |
| Placebo | PLACEBO_COMPARATOR | Participants receive matching placebo nasal spray BID for 16 weeks |
| Mometasone furoate nasal spray (MFNS) (50 μg spray device) | EXPERIMENTAL | The dose will be as follows: * 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks * 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks |
| MF placebo nasal spray | PLACEBO_COMPARATOR | Administration will be as follows: * 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks * 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks |
| MFNS 50 μg device | EXPERIMENTAL | MFNS 50 μg spray device. The dose will be as follows: * 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning. * 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning. |
| Arm 1 | EXPERIMENTAL | Mometasone furoate nasal spray 200 mcg QD (once per day) |
| Arm 2 | PLACEBO_COMPARATOR | Matching placebo nasal spray |
| Mometasone furoate nasal spray | EXPERIMENTAL | Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning. |
| Placebo nasal spray | PLACEBO_COMPARATOR | Placebo nasal spray once daily (two puffs per nostril) in the morning. |
| MFNS 200 mcg QD | EXPERIMENTAL | - |
| MFNS 100 mcg QD for subjects 6 to less than 12 years | EXPERIMENTAL | Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age |
| Placebo QD for subjects 6 to less than 12 years | PLACEBO_COMPARATOR | - |
| MFNS 200 mcg QD for subjects 12 to less than 18 years | EXPERIMENTAL | - |
| MFNS 200 mcg BID for subjects 12 to less than 18 years | EXPERIMENTAL | - |
| Placebo QD for subjects 12 to less than 18 years | PLACEBO_COMPARATOR | - |
| MFNS 100 mcg BID for subjects 6 to less than 12 years | EXPERIMENTAL | - |
| Placebo BID for subjects 6 to less than 12 years | PLACEBO_COMPARATOR | - |
| Placebo BID for subjects 12 to less than 18 years | PLACEBO_COMPARATOR | - |
| Mometasone Nasal Spray | EXPERIMENTAL | Open-label. Two sprays per nostril once daily (200 mcg/day). After 4 weeks, dose can be decreased to one spray per nostril daily or increased to 4 sprays per nostril daily. |
| New Formulation Group | EXPERIMENTAL | - |
| Old Formulation Group | ACTIVE_COMPARATOR | - |
| 1 | ACTIVE_COMPARATOR | MFNS once daily |
| 2 | EXPERIMENTAL | MFNS twice daily |
| 3 | ACTIVE_COMPARATOR | Amoxicillin |
| 4 | PLACEBO_COMPARATOR | Placebo |
| MFNS 25 mcg QD | EXPERIMENTAL | Mometasone furoate nasal spray 12.5 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. |
| MFNS 100 mcg QD | EXPERIMENTAL | Mometasone furoate nasal spray 50 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening), daily for 4 weeks. A matching placebo nasal spray was administered intranasally (1 spray per nostril) in the evening. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. |
| BDP 84 mcg BID | ACTIVE_COMPARATOR | Beclomethasone dipropionate nasal spray 42 mcg/spray was administered intranasally, one spray per nostril in the morning (upon awakening) and in the evening, daily for 4 weeks. Chlorpheniramine maleate syrup 2 mg/5 mL was to be used for relief of intolerable SAR symptoms. |
| MFNS 200 µg + Loratadine 10 mg | EXPERIMENTAL | Daily administration of 200 µg of MFNS plus oral dose of 10 mg loratadine tablet. |
| MFNS 200 µg | ACTIVE_COMPARATOR | Daily administration of 200 µg of MFNS plus oral placebo tablet. |
| Loratadine 10 mg | ACTIVE_COMPARATOR | Daily administration of oral dose of 10 mg loratadine tablet plus placebo nasal spray. |
| Fluticasone propionate nasal spray | ACTIVE_COMPARATOR | Participants receive 200 mcg of fluticasone propionate nasal spray and mometasone furoate placebo matching nasal spray once daily. |
| Mometasone Furoate (MF) | EXPERIMENTAL | Participants receive 200 mcg nasal MF in the morning upon awakening and placebo approximately 12 hours later in the evening (200 mcg total daily dose) for 29 days. |
| Beclomethasone Dipropionate (BDP) | ACTIVE_COMPARATOR | Participants receive 168 mcg nasal BDP in the morning upon awakening and an additional 168 mcg approximately 12 hours later in the evening (336 mcg total daily dose) for 29 days. |
| Mometasone furoate nasal spray 100 mcg QD | EXPERIMENTAL | - |
| Mometasone furoate nasal spray 200 mcg QD | EXPERIMENTAL | - |
| Mometasone furoate nasal spray 400 mcg QD | EXPERIMENTAL | - |
| Mometasone furoate nasal spray 100 mcg BID | EXPERIMENTAL | - |
| Mometasone furoate nasal spray 200 mcg BID | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | DRUG | MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks |
| Placebo for MFNS | DRUG | Two sprays in each nostril BID for up to 16 weeks |
| Mometasone furoate | DRUG | The study drug is MFNS (50 μg spray device) and the dose will be: * 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks * 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks |
| Placebo | DRUG | MF Placebo nasal spray and administration will be as follows: * 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks * 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks |
| Matching placebo nasal spray | DRUG | Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days |
| Placebo nasal spray | DRUG | Placebo nasal spray once daily (two puffs per nostril) in the morning. |
| Mometasone Furoate nasal spray | DRUG | Mometasone Furoate nasal spray 1 puff (50 mcg) per nostril twice daily x 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months). |
| MFNS | DRUG | Placebo capsules three times daily for 10 days, and MFNS 50 mcg/spray, 2 sprays in each nostril twice daily for 15 days followed by 14-day no-treatment observation period |
| Amoxicillin | DRUG | Amoxicillin 500 mg/capsule, one capsule 3 times a day for 10 days and placebo nasal spray twice daily for 15 days, followed by a 14-day no-treatment observation period |
| Beclomethasone dipropionate nasal spray | DRUG | intranasal administration |
| Chlorpheniramine maleate syrup | DRUG | oral administration |
| Loratadine | DRUG | Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days. |
| Placebo tablet | DRUG | Daily dose of placebo administered as an oral tablet for 15 days. |
| Fluticasone propionate | DRUG | Fluticasone propionate nasal spray, 200 mg once daily |
| Mometasone furoate placebo | DRUG | Mometasone furoate placebo matching nasal spray, once daily |
| Fluticasone propionate placebo | DRUG | Fluticasone propionate placebo matching nasal spray, once daily |
| Mometasone Furoate (MF) | DRUG | Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks. |
| Beclomethasone Dipropionate (BDP) | DRUG | Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) \[336 mcg total dose per day\] for 4 weeks. |
Inclusion Criteria: * Must be Chinese * Must have a diagnosis of bilateral nasal polyps * Clinically significant nasal congestion/obstruction must be present * Must be in good health, free of any clinically significant disease that would interfere with the study schedule or procedures, or compromis...